Effectiveness of Two Different Forms of Marine Oil on Indirect Markers of Muscle Damage and Soreness in Untrained Men
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|ClinicalTrials.gov Identifier: NCT03760757|
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Inflammation; Muscle||Dietary Supplement: ESPO-572® Dietary Supplement: PCSO-524®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled non-inferiority trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effectiveness of Two Different Forms of Marine Oil, Derived From the New Zealand Green Lipped Mussel and Krill Oil, on Indirect Markers of Muscle Damage and Soreness During Recovery From Muscle Damaging Exercise in Untrained Men|
|Actual Study Start Date :||February 11, 2019|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: PCSO-524® (no krill oil)
Four total capsules per day (2 in the morning; 2 at night) for 29 days. Amounts per day equal to 800 mg olive oil, 400 mg lipid extract (~58 mg EPA and 44 mg DHA) and 1.8 mg vitamin E (d-alpha-tocopherol).
Dietary Supplement: PCSO-524®
PCSO-524® (Lyprinol®/Omega XL®) is a nutritional supplement containing a patented extract of highly condensed form of stabilized marine lipids from the New Zealand green lipped mussel (Perna canaliculus) that is combined with olive oil and vitamin E. This marine oil lipid and omega-3 polyunsaturated fatty acid (PUFA) blend is a diverse mixture of sterol esters, sterols, polar lipids, triglycerides, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (split between the triacylglycerol and polar lipid classes), and free fatty acids.
Experimental: ESPO-572® (75% PCSO-524®, 25% krill oil)
Four total capsules per day (2 in the morning; 2 at night) for 29 days. ESPO-572®, a 75/25% PCSO-24®/Krill oil blend. Each capsule of the ESPO-572® contains green lipped mussel oil, krill oil, olive oil and vitamin E.
Dietary Supplement: ESPO-572®
ESPO-572® is the same as PCSO-524®, except it has krill oil added to it.
- Creatine Kinase [ Time Frame: Four days ]
Muscle damage markers: Muscle creatine kinase will be measured using a Beckman DU® Spectrophotometer (Beckman Coulter Inc., Brea, CA) at 360nm using a fluorometric assay kit (Cayman Chemicals, Ann Arbor, MI).
- Skeletal muscle slow troponin I [ Time Frame: Four days ]
Muscle damage markers: Skeletal muscle slow troponin I, (Novus Biologicals LLc., Littleton, CO).
- Interleukin-1 Beta [ Time Frame: Four days ]
Muscle inflammation markers: Interleukin-1 Beta (Cayman Chemicals, Ann Arbor, MI) will be analyzed using enzyme-linked immunoassay (ELISA).
- Tumor necrosis factor-alpha [ Time Frame: Four days ]
Muscle inflammation markers: Tumor necrosis factor-alpha (Cayman Chemicals, Ann Arbor, MI) will be analyzed using enzyme-linked immunoassay (ELISA).
- Isometric torque [ Time Frame: Four days ]
Isometric torque: Isometric torque assessment of the dominant leg extensors will be conducted at a knee angle of 80°flexion (measured by a goniometry) using a Cybex Isokinetic System (Medway, MA).
- Range of motion [ Time Frame: Four days ]
Measurement of knee flexion range of motion
- Swelling [ Time Frame: Four days ]
Limb girth measurements are used to test for the presence of swelling/edema within a muscle.
Units: percentage change from baseline
- Delayed onset muscle soreness [ Time Frame: Four days ]
Visual analog scale of muscle soreness (delayed onset muscle soreness; DOMS) - Knee extensor soreness will be assessed using a visual analogue scale with "no soreness" indicated at one end (score 0) and "unbearably painful" at the other (score 10).
Units: Arbitrary units
- Pressure pain threshold [ Time Frame: Four days ]
A hand-held pressure algometer (Algometer®, Somedic Sales, Hörby, Sweden) will be used to monitor pressure induced pain at five specific sites on the quadriceps.
Pressure pain threshold units: percentage change from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760757
|Contact: Matthew J Barenie, M.S.||email@example.com|
|Contact: Jessica Freemas, M.S.||firstname.lastname@example.org|
|United States, Indiana|
|Indiana University School of Public Health||Recruiting|
|Bloomington, Indiana, United States, 47405|
|Contact: Timothy D Mickleborough, PhD 812-855-0753 email@example.com|
|Principal Investigator:||Timothy D Mickleborough, Ph.D.||Indiana University|